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spk09: Good day and thank you for standing by. Welcome to the G1 Therapeutics First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require assistance during the conference, please press star 0. I would now like to hand the conference over to Will Roberts, Head of Communications. Please go ahead.
spk01: Thank you, Abigail. Good morning, everyone, and welcome to the G1 conference call to discuss our first quarter of 2022 financial results and business update. The press release on these financial results was issued this morning and can be found in the news section of our corporate website, g1therapeutics.com. On this morning's call, the team will provide a business overview of the first quarter of 2022, including an update on our clinical programs and our commercial progress in that period with Casella, which is approved and commercially available to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum etoposide-containing regimen or a topotecan-containing regimen for extensive-stage small cell lung cancer, or ES-SCLC. A question and answer session will follow the prepared remarks. Before we begin, I'd like to remind you that today's webcast contains forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risk and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on such risk and uncertainties, Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, May 4th, 2022. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Raj Malek, our Chief Medical Officer, and Jack Moses, our Chief Financial Officer. I'll now turn the call over to Jack. Jack? Thanks, Will.
spk05: Good morning, everyone, and thank you for joining us on the call today. Today's headline is that as of the beginning of March, we have successfully deployed our G1 sales team, fully transitioned out of our sales relationship with Behringer Ingelheim, and in doing so have entered a new phase of COSELLA promotion in which we are in full control of the commercial opportunity for this important drug. COSELLA is a unique and innovative drug. that can fundamentally change the paradigm by which small cell lung cancers are treated. It's proactively administered and covers multiple lineages, unlike what practitioners have been doing for the last 30 years, namely treating hematologic events caused by chemo reactively with a variety of single lineage interventions which carry their own unintended consequences. Our goal over time is to replace these reactive treatment modalities with COSELLA, a simple 30-minute infusion prior to chemo to reduce and in some cases eliminate the cytotoxic events that put chemo patients in the hospital and prevent them from completing their regimens. We are excited about this, as are the people we hear routinely from, including patients who have been through chemotherapy with COSELLA, infusion center nurses on the front line of patient care, and treating oncologists. As you will hear from Andrew, our newly deployed sales team made good progress during the back half of the first quarter in improving Cosella access and uptake. Intent to use remains high, and reimbursement remains as strong as it has been since launch. Importantly, ordering by our top 100 organizations increased quarter over quarter, and more broadly, we continued to shift the proportion of our business toward those top 100 organizations. So not only did overall volume increase, it increased in the accounts that have the ability to maximize the future potential of CoSella. Turning to our clinical operations, we continue to make good progress in enrollment in our ongoing Phase II and Phase III trials. And as of today, we are on plan to provide initial results on schedule. This morning, I will ask Andrew to cover our recent commercial progress, including an update on the first quarter of 2022 and month-over-month progress during the quarter, the first opportunity in which we were in full control of the commercialization effort. Raj will then provide an update on some of our medical and clinical momentum, including the real-world data we recently presented at the 2022 NCCN meeting. Finally, Jen will provide the financial results for the quarter, including a reminder that our cash runway takes us into 2024. Then I'll be back for some concluding comments. With that, I will turn the call over to Andrew.
spk06: Thank you, Jack. I'm glad to be with you today to spend some time on a variety of commercial topics, including first quarter sales activity and leading indicators of growth. This has been a quarter of significant commercial transition, and so we're also providing a special snapshot of monthly sales growth during the first quarter to provide additional insight into this transition. We began the first quarter of 2022 with COSELLA still being promoted by BI, our co-promotion partner since launch, and with the first few of our G1 oncology sales account managers, or OSAMs, in the field. By mid-February, we had deployed our complete team of 34 G1 OSAMs, and by March 2nd, the BI arrangement had been concluded. So in March, Cosella was solely promoted by the G1 sales team for the first time. We continue to be encouraged by the market reception for Cosella across payers, providers, and healthcare organizations. Payer coverage, brand awareness, and intention to prescribe all remain strong. And we're seeing that translate into physician endorsement and account-level trial and uptake with our largest customers. Coming out of the first quarter, we believe we now have a commercial platform which will allow us to generate growth through both breadth and depth. Starting with first quarter sales activity, we ended the quarter with $5.5 million in net sales of Cosella, representing just over 20% file volume growth period over period. As previously mentioned, the first quarter was one of significant transition as we moved into the next phase of Cosella commercialization. And our goal during this transition period was to maintain growth at a similar level to the growth we saw in quarter four of last year when BI were still promoting the brand. We were successful in doing so. The first quarter grew approximately 20% versus Q4 compared with approximately 22% growth in the prior quarter. When we look at the snapshot of Q1 growth data on a monthly basis, we can start to see the progress of this transition and the impact of our sales team. In January 2022, we saw vial volumes nationally decline 2% compared with December 2021. But in those seven territories with the G1 OSAM, vial volumes doubled. In February, we had 13 G1 OSAMs in the field until our full deployment mid-month. and we saw month-over-month volume growth of 5%. After March 2nd, we no longer had support from the BI team. We saw four consecutive weeks of all-time high vial volumes, culminating in 38% monthly volume growth over February. Just over 70% of our first quarter demand came from community hospitals or clinics, with the remainder being academic institutions. Moving to our account level performance, as a reminder, one of the reasons for recruiting our own sales team was to bring in extensive account knowledge and provider relationships with the top 100 healthcare organizations which treat around 50% of eligible patients with extensive stage small cell lung cancer. We were pleased to see Cosella trial and uptake in nine new top 100 organizations during the first quarter to bring the total number of top 100 organizations with Cosella utilization to 53 by end of Q1, and we see an overall reorder rate of around 80% in those 53 organizations. Since the end of the quarter, we were informed that MD Anderson Cancer Center in Houston had added Cosella to formulary, and we have seen their first order come through as well, taking us to 54 of our top 100. Uptake and endorsement from a large organization like MD Anderson has the ability to alter our sales trajectory. However, getting on formulary itself can be just a step in the process. Further physician-level education and in-service programs with nursing will follow to ensure success. Several of these top 100 organizations have now not only incorporated COSELLA into their formularies and EMRs, they have also specified it as a standard of care within their order set for extensive-stage small cell lung cancer. And in these examples, sales growth can occur very rapidly. As a result of this focus on the large organizations with more patient potential, We have not only added breadth with more of the top 100 organizations ordering, but we've been able to shift our priorities toward driving depth of uptake across the many clinics and accounts which form part of those larger organizations. In fact, our median vial volume in our top 100 organizations ordering has increased by 140%, comparing Q4 of 2021 with Q1. Last year, the proportion of our total business from top 100 organizations hovered between 40% and 50%. And in the most recent months, that proportion is now almost 60%. So not only have we been adding volume since bringing our new sales team on board, we have done so by accessing more top 100 organizations and by driving additional uptake within those organizations. As a result, we now believe we have more of a platform which can sustain our future growth ambitions. With the next phase of COSELLA commercialization underway, we remain confident in the appeal of COSELLA in the marketplace. Our new G1 sales team are fully deployed and are benefiting from an increase of in-person engagements as more clinics open up to appointments, programs, and exhibits. Brand awareness remains over 80%, and among oncologists who are aware of COSELLA, intention to use is over 85%. The path of those respondents saying they anticipate using COSELLA in the next two months. We also know that our Cosella messaging is resonating with customers. In Q1, our key messages outperformed the industry average for oncology brand message effectiveness. And of course, reimbursement coverage remains excellent. As a reminder, approximately 60% goes through Medicare and 30% through commercial pay. We've had terrific coverage from the word go with very few pair rejections. Overall, I'm pleased with the progress we made during Q1 in transitioning to the next commercial phase. We retained our key customers, expanded our base of prescribers, and created a platform for strong growth. We continue to see examples of rapid growth in individual accounts, and we have a number of physician advocates who are ready to champion COSELLA with their colleagues. We have excellent payer coverage and a strong health economic value proposition. Yet, of course, we believe there is significant unmet need and potential remaining for COSELLA. Our sales and marketing teams are focused on promoting the unique benefits of Cosella and ensuring the relevant customer systems and processes are updated to allow for its use. But in addition, recent scientific presentations using real-world data have begun to demonstrate the extent of the unmet need faced by our customers and outline the benefits that are seen with Cosella. Going forward, we anticipate more of this real-world data emerging with support for Cosella, and we look forward to working with healthcare providers to ensure their experience can be communicated turn the call over to Raj for a medical and clinical update. Raj?
spk07: Thanks, Andrew, and good morning, everyone. I want to first discuss some compelling real-world data that we recently presented at the National Comprehensive Cancer Network, or NCCN, conference on the benefit that Casella provides patients, and then remind listeners of our current expectations for data from our ongoing Phase II and Phase III trials of trialacyclin. The NCCN data is described the substantial burden of myelosuppression and its impact on healthcare resource utilization and the impact that pretreatment with Trilocyclib can have on patients with small cell lung cancer receiving chemotherapy. In the study, the researchers conducted an analysis of 3,277 patients who received chemotherapy alone and 21 patients who received Trilocyclib prior to chemotherapy, including 17 who received commercial tricyclic in the real-world setting. Utilizing data from the Integra Connect database, the researchers quantified the frequency of grade 3 or greater myelosuppressive hematological adverse events, or HAEs, including neutropenia, anemia, or thrombocytopenia, and associated healthcare resource utilization, including supportive care and all-cause hospitalizations. The results were consistent with those from our clinical trials, showing that the use of Tavacyclib prior to chemotherapy was associated with an approximately 50% reduction in patients with one grade three or greater HAE and a 74% reduction in the percent of all-cause hospitalizations up to 21 days after treatment compared to patients who received chemotherapy alone. Among patients with grade three or greater HAEs in one blood cell lineage, the use of Trelacyclib prior to chemotherapy was associated with an 86% reduction in thrombocytopenia, a 58% reduction in anemia, and a 57% reduction in neutropenia compared to patients who did not receive Trelacyclib. Regarding patients with grade 3 or greater HAEs in two blood cell lineages, the use of Trelacyclib was associated with a 100% reduction from 20% to 0% in patients experiencing anemia and thrombocytopenia, a 76% reduction in both neutropenia and anemia, and a 79% reduction in both neutropenia and thrombocytopenia, compared to patients receiving chemo alone. The use of Trelacyclib prior to chemotherapy eliminated three or greater HAEs in all three lineages in this evaluation. No patient receiving Trelacyclib experienced cytopenia in all three lineages. compared to 15% of patients who did not receive Trelacycline. Importantly, use of Trelacycline also had a remarkable impact on all-cause hospitalization. No patient receiving Trelacycline prior to chemo was hospitalized between days 8 and 16 after initiation of chemotherapy, compared to just over 7% of patients receiving chemo alone. And only one patient, or 4.8%, who received Trelacyclib was hospitalized between days 1 and 21, compared to 19 percent of patients who received chemo only. These data are very compelling, and we look forward to presenting more real-world data as they become available. Regarding our clinical program, I can report that as of today, we remain on track to provide initial results from our ongoing clinical trials in the timelines we have previously disclosed. We currently expect initial data from our three ongoing Phase II trials in the fourth quarter of this year. These include the following. Overall response rate and myeloprotection endpoints from PRESERVE-3, our study of Trelacycline with chemotherapy and the immune checkpoint inhibitor Evelumab in patients with bladder cancer receiving first-line treatment. Overall response rate and myeloprotection endpoints from our trial in 45 triple-negative breast cancer patients designed to evaluate the additive combination potential of trilocyclic with Tredelvi, an antibody drug conjugate, or ADC. And initial data evaluating immune changes in the tumor microenvironment across the cancer immunity cycle from our mechanism of action study designed to confirm our understanding of the immune-based mechanism of action of trilocyclic and its ability to modulate the tumor immune microenvironment. Regarding our ongoing phase three trials, this has been a challenging time for all companies, including ours, who conduct clinical trials in Ukraine. Our mitigation efforts have included working closely with our CRO partners on business continuity and assistance in relocating some Ukrainian trial patients, thereby allowing them to remain on schedule with these trials. First, we expect to release initial data, including results from model protection and overall response rate endpoints from PRESERVE-1, our ongoing line extension trial of Trialacyclid, in first-line colorectal cancer in the first quarter of next year. We experienced significant acceleration in patient enrollment in this trial during the first quarter, allowing us to complete enrollment of the protocol-specified number of patients. However, we are now enrolling additional patients to make up for those from whom we may not be able to collect follow-up data due to the geopolitical situation in Ukraine. Second, we expect initial data, including interim results for overall survival from PRESERVE-3, our first-line triple negative breast cancer pivotal trial, in 170 patients with PD-L1 positive and negative tumors in the second half of next year. This trial is designed to follow up on the exciting, Statistically significant improvements in survival we observed in our Phase II triple negative breast cancer trial. With that, I'll turn the call over to Jen for a review of the financial results for the first quarter of 2022. Jen?
spk08: Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the first quarter of 2022 are available in this morning's press release and will be in the 10-Q, which we intend to file today after market close. Our total revenue for the first quarter of 2022 was $6.9 million, comprised of net COSELLA revenue of $5.5 million and license revenue of $1.4 million. Our license revenue for the quarter was primarily related to clinical trial reimbursements from EQRX and Sincere. Cost of goods sold for the three-month ended March 31, 2022, was $0.7 million. As a reminder, the majority of the manufacturing costs related to Cosella sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods. These costs will continue to impact the presentation of cost of goods sold in future periods until initial prelaunch inventory is fully depleted. Our research and development expenses for the first quarter of 2022 were $26.3 million compared to $16.5 million for the first quarter of 2021. The increase in R&D expense was primarily due to an increase in clinical trial spend. Accelerated enrollment in our CRC trials and ramping enrollment in our other Phase 3 and Phase 2 trials drives a large increase in R&D costs this quarter. This ramp and the related costs were anticipated. And because of ongoing supply chain issues due to COVID and the mounting concerns in Ukraine in the first quarter, we made the decision to accelerate shipments of supplies and co-meds to our European sites during this period. As a result, our R&D line for the 2022 year is front-loaded, and the first quarter should be the highest quarter of R&D expense in 2022. We expect R&D to remain above 2021 levels but decrease as the year goes on. Our selling, general, and administrative expenses for the first quarter of 2022 were $26.7 million compared to $23 million for the first quarter of 2021. The increase in SG&A expenses quarter over quarter was largely due to an increase in personnel costs related to the completion of the hiring and deployment of our OSAMs. We expect our quarterly SG&A expenses to vary somewhat quarter to quarter, but stay in a range similar to that of Q1 for the rest of 2022. Regarding our cash position, as described in the press release this morning, we ended the first quarter with cash and cash equivalents of $183 million. compared to $221.2 million as of December 31st, 2021. We expect this to be sufficient to fund our operations and capital expenditures into 2024. This projection of cash runway includes the future draw of an additional $25 million on our debt facility with Hercules, which is currently available to us at our discretion, but has not yet been drawn down. While we may receive a $13 million milestone payment from our partners some year later this year, conditional upon approval of Trial of Cyclone in China, that payment, along with any future royalties, has not been considered in our current cash guidance. With that, I'll turn the call back over to Jack for some closing comments. Jack?
spk05: Thank you, Jen, Raj, Andrew, and Will. And as always, I want to thank people living with cancer for their inspiration. Caring for people living with cancer is at the core of what we do and who we are at G1. We remain driven and focused to ensure that we reach our goals for you and your family. Before I close the call, I have two final topics to cover. First, regarding Ritavestrant, as you saw in this morning's press release, after completing our evaluation of partnering options and data from recent clinical trials in the highly competitive oral CERV space, G1 has made the strategic decision to discontinue the program, including all clinical and partnering efforts, in order to focus our full attention on the development and commercialization of Trilocycline. G1 will responsibly wind down all remaining clinical efforts for Rintodestrin by the end of this year and revert the rights back to the originator, the University of Illinois. Importantly, for modeling purposes, there are no additional financial obligations due to the originator resulting from the reversion, and there will be no more spend of significance on this program. Second, in terms of guidance, as we have previously communicated, we intend to provide formal guidance as soon as we have enough data on the performance and impact of our G1 sales team to do so. Given that our G1 sales team has only been fully deployed since mid-February, we do not yet have the required data to do so at this point, but we intend to provide formal guidance on our August call for the second quarter of the year. As of today, we remain comfortable with analyst consensus for Tosella Net Sales in 2022, currently sitting just under $42 million. Before we move on to Q&A, let me just recap some key points that you have heard today. As of the beginning of March, our sales team is in the field in driving usage, and our partnership with BI has ceased. We are already seeing evidence of the impact of the sales team on driving growth, and their first full month in the field, March volume grew by 38% over February after two roughly flat months. We have seen that once an institution tries COSELLA, they tend to adopt it. Our reorder rate among the 53 top 100 organizations using the drug remains over 80%. and we continue to successfully shift the proportion of our business toward those top 100 organizations. Our medical team continues to present and publish important new data on Trilocyclib, including the first real-world data presented last month at NCCM. This data showed that the use of Trilocyclib prior to chemotherapy was associated with a variety of measures of improved outcome, including a 74% reduction in the percent of all-cause hospitalizations up to 21 days after treatment, compared to patients who received chemotherapy alone. We expect to provide initial results from three phase two trials later this year, the ABC combination, MOA, and bladder combination studies, and data from our two ongoing pivotal trials in CRC and TMDC next year. starting with CRC data in the first quarter of 2023. This means that as of today, over the next 10 months, we expect to announce the results of four clinical trials, including one pivotal phase three line extension trial. We are excited about the potential for trial-a-cyclib in all of these settings and are also well along developing important preclinical data on the potential synergistic effect of trial-a-cyclib on a variety of other novel anti-cancer modalities. We look forward to hosting an R&D day with you later this year to discuss these data ahead of the data readouts from these trials. Thank you for taking the time this morning. We will speak again in this format in August on the second quarter 2022 call. With that, I will close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask a question?
spk09: As a reminder, to ask a question, you will need to press JAR 1 on your telephone. To withdraw your question, press the pound key. Our first question comes from Gil Bloom with Needham & Company. Your line is open.
spk04: Good morning, everyone, and thanks for taking our questions. First of all, congratulations on rolling out your Salesforce. So maybe a question relating to that. It looks like you had a pretty big bump in March last month over month. Do you think this is a bolus, or should we continue to expect acceleration throughout the year? Is there any way to think about this?
spk06: Yeah, thanks, Bill. It's Andrew here. We were very pleased to see that bump in March, and I think it's a product of our sales team being able to access those top 100 organizations, being able to bring them on board, and also being able to access more debts there. We have continued to see growth in April, and we'll comment more on second-quarter growth as we move through the year. But we do believe, as I said on the call, that we've created a platform to generate, you know, this type of growth going forward.
spk04: Okay. Okay. And maybe considering your recent NCCN guideline updates and the data you've presented, can you tell us a little bit about the feedback you've been getting from prescribing physicians on this information?
spk07: Yeah, Rod, why don't you take that one? Yeah, so these data were just the real-world data. They did not result in an update in the guidelines. It was presented at the conference. And the feedback we've gotten has been very positive because really it's the first real-world evidence showing that Casella works as we expected it to work and similar to what we saw in our clinical trials. And particularly we were pleased to show the multilineage benefits.
spk04: All right. And maybe a last one, considering we're getting closer to pivotal readout for the colorectal cancer study, and that is a much larger indication. How do you think about a potential launch there? Do you expect synergies with small cell, or would there be required a big expansion of the sales force? How should we think about it?
spk06: At this point, we're still evaluating what that go-to-market strategy would be. I do think that our existing sales team has room in the bag to be able to incorporate certainly several of our future indications into their capability today, but we'll evaluate that as we get closer to a potential registration.
spk04: All right. And maybe a last one. Now with the discontinuation of Rento, How should we think from a cost-saving perspective on, you know, OPEX looking forward?
spk08: Yeah, I know, Jen. I think, as I described, I think we're really expecting this R&D level to be the highest of the year for this quarter. So I think you should see a decrease of that over the year. And, yeah, really the bulk of activity, we're in the middle of it right now. So we're seeing a very high level currently.
spk05: And I think specifically to rinse out, Gil, you know, we really look at that as the minimus. What small amount was being spent on it will stop by the end of this year just so we can conclude all the normal things that you have to do to wind up the studies that were existing on this. But it's the minimus overall.
spk04: Okay. That makes sense. Thank you so much for taking our questions this morning, and congrats on your progress. Thank you, Gil.
spk09: Our next question comes from the line of Kaveri Pullman with BTIG. Your line is open.
spk10: Good morning, and thanks for taking my questions. My first question is for colorectal cancer. I believe you'll gather myeloprotection benefit data faster than the survival data. Does it make sense to submit an NDA based on that data and file later for anti-tumor activity?
spk07: Hi, Kaviri. This is Raj. I can answer that. Yeah, that's exactly our intention. So when the model protection data are available in the first quarter of next year, assuming they're positive, we will have discussions with the agency about filing.
spk10: Great. And then regarding bladder cancer study, I understand the readout this year will mostly focus on ORR, but any thoughts on durability or survival? Sure. Perhaps you could just help us understand what duration of response and or survival, which is the primary endpoint here, is clinically meaningful.
spk07: Yeah, Raj here again. You know, I think since the trial is currently ongoing, as you know, the durability and PFS data, particularly PFS as the primary readout, will require a longer follow-up. So we'll report the early data that we have, but expect more meaningful data on PFS and durability next year.
spk10: Appreciate it. Thanks.
spk09: Our next question comes from the line of Ed White with HC Wainwright. Your line is open.
spk02: Good morning. Thanks for taking my questions. So the first one is just on – Gross to net, if you could let us know what that number is. And, you know, you mentioned reimbursement. I'm just wondering more about reimbursement at these top 100 accounts. The ones that you haven't penetrated yet, has reimbursement been an issue or are there any issues with those other accounts that you haven't been able to penetrate yet?
spk08: Hi, Ed, it's Jen. On growth to net, we're in the range I'd given previously to high teens. We're continuing to believe that that'll hold going forward, so I'd just reiterate that guidance that we gave on a previous call.
spk06: Yeah, and I think, Ed, on the reimbursement, pro-party payer reimbursement for COSELLA has that is not a barrier. I think there's an opportunity with many of those top 100s to actually educate them on the health economic value propositions that our payers did gravitate to early in the adoption cycle. And that argument has only got more compelling, and I think with these real-world data, it continues to be compelling. So we anticipate more of those top 100s coming on board as we move forward. And in fact, we do continue to see top 100 accounts come on board regularly, as I just outlined with Eddie Anderson.
spk02: Great. Thanks, Andrew. And one last question for you. I'm just curious, is the 34 sales reps that you currently have, are you right-sized now, or will you be adding more, you know, later in the year?
spk06: Yeah, right now we are fully deployed with the 34. We don't have an intention to expand that based on the current potential that we have. And I've got to say, those 34 individuals are very, very capable people, and I think they have a lot of potential to deliver for the business.
spk02: Okay. Thanks, Andrew. Thanks, everyone, for taking my questions. Thank you.
spk09: Our next question comes from the line of Anupam Rama with J.P. Morgan. Your line is open.
spk12: Hey, guys. Thanks so much for taking the question. What portion of COSELLA detailing is in-person versus online? versus virtual, and how is this dynamic sort of trended over the first four months of the year with the Salesforce expansion? And have you seen any difference in uptake if the primary detailing is in-person versus virtual? Thanks so much.
spk06: Yeah, thanks, Anupam. Yeah, we now see pretty much 50% of our details are in-person. Obviously, there's the background trend of COVID there. We've got the changeover of our sales team going on as well. But we do see account access opening up as well. Many of our top accounts were really closed down to everyone, including, in many cases, caregivers of patients or family members of patients. service opportunities to make sure that folks are educated on how to administer the product, as well as exhibits that customers are now attending as well. Any difference between the two? Between live or virtual? Oh, yeah, in terms of, you know, we haven't really analyzed the difference in image and virtual, so I don't really have data to back that up. But I would say that the efficiency of a live interaction is certainly much higher because when you're in the office, you do get the opportunity just to see multiple stakeholders at the exact same time and potentially have them in the room together. So although I don't have data to back up the effectiveness, I'm pretty sure it's a much more efficient method.
spk12: Thanks so much for taking our question. Thank you, Anupam.
spk09: Our next question comes from the line of Tony Butler with Ross Capital. Your line is open.
spk03: Good morning. This is for Tony. Our question is on small to long cancer patients. I wonder if you can shed some light on the proportion of patients completing all of their chemo doses, and then perhaps it would be also great to know if you could tell us the average number of COSLA doses that each patient get at front line, second line, third line settings.
spk06: Thank you. Yeah, thanks for the question. I can give you some of the information I have, which is that over 90% of our patients are first line. So the vast majority are first line. On average, we anticipate that they probably go through about 20 vials of Costella. So 24 would be the full labeled dosing for first-line patients. and we see the real-world information start to reflect what we saw in the clinical trials, it will be interesting to form more of a picture of them.
spk03: Thank you, Andrew. Thanks.
spk09: As a reminder, if you'd like to ask a question, please press star 1 on your telephone keypad. Our next question comes from the line of Troy Langford with Cohen. Your line is open.
spk11: Hi, thanks for taking our questions, and congrats on all the progress. This is Troy. I'm for Joe. I just have a couple of quick questions around the Costello launch. So first of all, you all mentioned a couple of metrics to measure depth of uptake among the several key accounts on the call. So do you all have a target number that you hope to achieve in this regard? And I guess how much more room do you think you'll have to grow these numbers? And then I have a follow-up.
spk06: Yeah, so, you know, right now in our top 100 organizations, I would estimate, and this is really an estimate because it relies on a lot of kind of calculation, I'd estimate our depth is about 15%. And so there's clearly significant growth there. Now, you know, why is it only 15%? Well, in some of those top 100 organizations, where we have been put in an advantage, And when that happens, we see very, very rapid adoption. But there are other circumstances, obviously, where they've just started to come on board. So I just talked about MD Anderson. We received their first order. We're on formulary. And obviously, their depth right now is low because they're right at the beginning of the curve of uptakes. But clearly, there is potential when an organization uses Cosella, sees the benefits of Cosella, for them to put it in a position where it is the expectation that it is used with every eligible extensive stage small cell lung cancer patient. So our role there would be to make it the exception where Cosella was not used.
spk11: Okay, great. That's really helpful. And then just on the Cosella sales force, so now that it's launched, is what additional levers do you all think you have that you can pull to increase Coachella adoption?
spk06: Yeah, so right now, you know, what I'm really excited about, actually, is the potential for peer-to-peer exchange, because as we've developed more Coachella advocates, and I've got to say, I've had physicians actually call me through the switchboard to campaign for more Coachella uptake in their accounts, and I've had to tell them that we're doing everything But as our representatives, as our OSAMs get out there, they see that, they develop those physician champions, and those physicians decide to communicate their experience to the other physicians in the account. And as we see nurses have the same experience and pharmacists have the same experience, making sure that that peer-to-peer exchange is happening becomes really a critical lever for us to build going forward.
spk11: Okay, great. That really helps.
spk09: Our next question comes from the line of Tony Butler with Roth Capital. Your line is open.
spk03: Hi, this is Tasha again, and this one's for Jennifer. It's possible I missed your point about the 2022 R&D expenses being front-loaded. Could you please clarify? Thanks.
spk08: Sure. So our number for first quarter, this is our highest level of activity in our trials. As Raj mentioned, our CRC trials, we more or less fully enrolled for our initial number of patients. That happened earlier in the quarter than we anticipated. We're also adding additional patients for Ukraine. But on top of that, we did anticipate supply chain issues just from COVID and then also anticipating the Ukraine conflict. We wanted to go ahead and move supplies into the European sites. So we did front load a lot of those costs in the first quarter as well. So because of those two things, we really anticipate this first quarter to be the heaviest spend in R&D. We will still be above 2021 levels, obviously, for R&D because we have all of these trials ongoing, but we should see a decrease throughout the year. Very helpful.
spk09: I'm showing no further questions at this time. I'd like to turn the conference back to Jack Bailey, CEO.
spk05: Thank you, Abigail. As always, we look forward to keeping you all updated on our progress as we go forward. Certainly thank you for joining us today, and we just hope you all stay well. We look forward to being in touch soon. Thank you.
spk09: This concludes today's conference. Thank you for participating. You may now disconnect.
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